European Commission approves Filsuvez for the treatment of dystrophic and junctional epidermolysis bullosa .- Amryt
The European Commission has approved Filsuvez (Oleogel-S10) from Amryt for the treatment of skin wounds in adults and children, ages 6 months and older, with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB).
The decision makes Filsuvez, a topical gel, the first-ever therapy approved for EB wounds. Originally developed by Birken AG, which was later acquired by Amryt, Filsuvez is a gel based on an extract of birch tree bark that contains high amounts of a compound called betulin. Previous studies suggest that betulin, when applied to the skin, can promote wound healing by activating skin cells and suppressing inflammation.In 2016, the gel was approved in Europe under the brand name Episalvan for the treatment of partial-thickness skin wounds — those in which the top layers of the skin have been lost due to burns or skin grafts. Such wounds also occur in people with EB, a group of rare skin disorders characterized by extremely fragile skin that is prone to form blisters.
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